Currently, cell therapies administered by intravenous, intra-arterial, and/or direct tissue injection are limited by the lack of clinically available imaging methods to detect the in vivo fate of the administered cells. Current approaches to solve these problems are limited by potential safety issues including, but not limited to, radioactive exposure and/or heavy ion toxicity, and difficulty in serial tracking due to complex instrumentation and/or the requirement for repetitive radiation exposure.
The absence of a reliable technology for in vivo tracking of delivered biological cells has limited the progress and conduct of clinical trials of stem cell therapy. A robust imaging technology for serial, non-invasive, in vivo assessment of stem cell fate after delivery in humans would be a powerful tool, both for pharmaceutical companies conducting trials of cell therapies, as well as for clinicians who would ultimately implement the imaging technology to guide clinical decision making. Furthermore, such an imaging technology would be expected to be useful in the research arena, giving new physiologic insights into stem cell trafficking.
There are currently no reliable in vivo imaging methods for serial tracking of the fate of biological cells delivered for therapeutic purposes. Existing technologies for in vivo cell tracking, still in research stages, include magnetic resonance and nuclear imaging approaches which have disadvantages in terms of radioactive exposure of stem cells and complex instrumentation. What is needed in the art is a portable, non-invasive technique with relatively simple instrumentation, to allow safe, serial, imaging of systemically injected biological cells.